Saniona, FPWR Call Attention to Planned Phase 2b Tesomet Clinical Trial

The Foundation for Prader-Willi Research (FPWR) and Saniona are working together to inform patients and their families of an upcoming Phase 2b trial evaluating Tesomet as a potential treatment of Prader-Willi syndrome (PWS), and to best ensure community involvement.

Initiation of this study, which follows positive findings in a Phase 2a trial in adults and adolescents with PWS, is expected by June.

“There are currently no approved treatment options to manage hyperphagia, the uncontrollable hunger that is one of the most difficult symptoms of PWS, making clinical trials a high priority for the PWS community,” John Walter, CEO of the FPWR, said in a press release.

“We are pleased to partner with Saniona on this program to empower patients to learn about the clinical trial process, ensure that the patient view is represented throughout the clinical trial continuum, and raise awareness of Saniona’s clinical trial within the PWS community,” he added.

The two plan to provide more trial information and answer questions from the PWS community in an upcoming webinar. The foundation will also use its online, email, and social media platforms to raise awareness.

Tesomet recently was given orphan drug designation by the U.S. Food and Drug Administration, based partly on Phase 2a trial (NCT03149445) results of its safety and efficacy in people with PWS.

In that study, once-daily treatment with Tesomet at 0.25 mg was linked with a 69% decrease in hyperphagia over three months, while a 0.5 mg dose led to clinically meaningful weight loss in adults and adolescents as compared with measures taken at the study’s start.

A smaller extension study in adolescents indicated that Tesomet’s effect on weight and hyperphagia is dose-dependent, and that it is well-tolerated at lower doses (0.125 mg and 0.25 mg).

Tesomet is a combination of the molecules tesofensine and metoprolol.

Tesofensine stops certain nerve signals by preventing nerve cells from reabsorbing (effectively recycling) the messenger molecules dopamine, serotonine, and noradrenaline. It was first developed for neurodegenerative disorders, and a weight loss effect was found later.

Because tesofensine can induce irregular heart rhythms, is was combined with metoprolol, which improves circulation and lowers blood pressure.

“We are grateful to partner with FPWR because one of our top priorities is to incorporate caregiver and patient feedback into our clinical trial activities to ensure we meet the needs of the PWS community,” said Rudolf Baumgartner, MD, Saniona’s chief medical officer and head of clinical development. “We look forward to working with FPWR to gather this feedback and to increase awareness of our clinical trial.”

In addition to PWS, the company is investigating Tesomet’s potential to treat hypothalamic obesity, and plans to also begin a Phase 2b trial for that condition in the first half of the year.